Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation
Validation of Computed Inspiratory Muscle Pressure to Monitor Inspiratory Effort During Pressure Support Ventilation: A Prospective Physiological Study
The goal of this study is to validate computed inspiratory muscle pressure (cPmus) for monitoring inspiratory effort in adults receiving pressure support ventilation. Researchers will compare cPmus with reference inspiratory muscle pressure calculated using an esophageal balloon catheter, a thin pressure-measuring tube placed in the esophagus. The study will look at how closely the two methods are related and whether they give similar results. Participants will undergo simultaneous monitoring with cPmus and an esophageal balloon catheter. Researchers will adjust pressure support across six levels, recording measurements from both methods at each level.
Panoramica dello studio
Stato
Condizioni
Descrizione dettagliata
This is a prospective validation study with repeated measurements. It aims to validate computed inspiratory muscle pressure (cPmus), a noninvasive estimate of inspiratory muscle pressure provided by the study ventilator (Prunus Padus 9, Shenzhen, China). The reference method is esophageal pressure-derived inspiratory muscle pressure (Pmus). The study will enroll adults receiving invasive pressure support ventilation (PSV).
After obtaining informed consent, participants will undergo simultaneous monitoring with the cPmus algorithm and an esophageal balloon catheter. Pressure support will be adjusted in six levels. Positive end-expiratory pressure (PEEP) will remain unchanged. Each pressure support level will be maintained for 10 minutes. Brief end-expiratory and end-inspiratory occlusion maneuvers will also be performed at each level to obtain additional indices of respiratory drive and inspiratory effort. Esophageal balloon will be removed after completing the last pressure support step.
At each pressure support level, paired values of cPmus and reference Pmus were measured. The corresponding inspiratory pressure-time products, cPTPmus and PTPmus, will also be calculated.
All procedures will follow the study protocol and standardized measurement procedures. Study data will be recorded in case report forms and an electronic database, with checks for completeness, accuracy, and waveform quality.
Tipo di studio
Iscrizione (Stimato)
Fase
- Non applicabile
Contatti e Sedi
Contatto studio
- Nome: Jian-Xin Zhou, MD, PhD
- Numero di telefono: 8610 6392 6666
- Email: zhoujx.cn@icloud.com
Backup dei contatti dello studio
- Nome: Meng-Xue Hou, MD
- Email: himengxue@163.com
Luoghi di studio
-
-
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Beijing, Cina
- Reclutamento
- Beijing Shijitan Hospital
-
Contatto:
- Jian-Xin Zhou, MD, PhD
- Numero di telefono: 8610 6392 6666
- Email: zhoujx.cn@icloud.com
-
Contatto:
- Meng-Xue Hou, MD
- Email: himengxue@163.com
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
Inclusion Criteria:
- Age 18 years or older.
- Receiving pressure support ventilation.
- Written informed consent provided by the participant or a legally authorized representative.
Exclusion Criteria:
- Contraindication to esophageal catheter placement, including uncontrolled coagulopathy, skull base fracture, upper gastrointestinal bleeding, tumor or surgery, neck surgery, or esophagogastric varices.
- Chest trauma, a postoperative state following lung surgery, an active pulmonary air leak (pneumothorax, pneumomediastinum, or bronchopleural fistula), or an indwelling chest drain.
- Neuromuscular disease, diaphragmatic dysfunction, or diaphragmatic surgery.
- Impaired central respiratory drive due to intracranial hypertension or brainstem injury.
- Hemodynamic instability, defined as mean arterial pressure <60 mmHg, systolic blood pressure >180 mmHg, heart rate <40 or >150 beats/min, or norepinephrine dose >1 mcg/kg/min.
- Pregnancy or breastfeeding.
- A decision to withdraw life-sustaining treatment or provide palliative care.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Diagnostico
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione incrociata
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: Pressure support 15
Pressure support of 15 cm H2O will be applied for 10 minutes. |
Pressure support of 15 cm H2O will be applied for 10 minutes. |
|
Sperimentale: Pressure support 13
Pressure support of 13 cm H2O will be applied for 10 minutes. |
Pressure support of 13 cm H2O will be applied for 10 minutes. |
|
Sperimentale: Pressure support 11
Pressure support of 11 cm H2O will be applied for 10 minutes. |
Pressure support of 11 cm H2O will be applied for 10 minutes. |
|
Sperimentale: Pressure support 9
Pressure support of 9 cm H2O will be applied for 10 minutes. |
Pressure support of 9 cm H2O will be applied for 10 minutes. |
|
Sperimentale: Pressure support 7
Pressure support of 7 cm H2O will be applied for 10 minutes. |
Pressure support of 7 cm H2O will be applied for 10 minutes. |
|
Sperimentale: Pressure support 5
Pressure support of 5 cm H2O will be applied for 10 minutes. |
Pressure support of 5 cm H2O will be applied for 10 minutes. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Computed inspiratory muscle pressure (cPmus)
Lasso di tempo: 2 hours
|
Computed inspiratory muscle pressure (cPmus) will be measured. |
2 hours
|
|
Inspiratory muscle pressure (Pmus)
Lasso di tempo: 2 hours
|
Inspiratory muscle pressure (Pmus) will be measured. |
2 hours
|
|
Computed inspiratory muscle pressure-time product (cPTPmus)
Lasso di tempo: 2 hours
|
Computed inspiratory muscle pressure-time product (cPTPmus) will be measured. |
2 hours
|
|
Inspiratory muscle pressure-time product (PTPmus)
Lasso di tempo: 2 hours
|
Inspiratory muscle pressure-time product (PTPmus) will be measured. |
2 hours
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Occluded airway pressure at 100ms (P0.1)
Lasso di tempo: 2 hours
|
Occluded airway pressure at 100ms (P0.1) will be measured. |
2 hours
|
|
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc)
Lasso di tempo: 2 hours
|
Maximal decrease of airway pressure during end-expiratory occlusion (∆Pocc) will be measured. |
2 hours
|
|
Pressure muscle index (PMI)
Lasso di tempo: 2 hours
|
Pressure muscle index (PMI) will be measured. |
2 hours
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: Jian-Xin Zhou, Capital Medical University
Studiare le date dei record
Studia le date principali
Inizio studio (Effettivo)
Completamento primario (Stimato)
Completamento dello studio (Stimato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Effettivo)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Effettivo)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Altri numeri di identificazione dello studio
- IIT2026-032-002
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